摘要
目的:建立盐酸雷尼替丁制剂有关物质检查的RP-HPLC法。方法:采用Waters C18(250 mm×4.6 mm,5μm)色谱柱;以甲醇-0.77%醋酸铵溶液(40∶60)为流动相;检测波长:320 nm;柱温:40℃。自身对照法。结果:其有关物质的峰面积之和不超过对照品主峰面积的3倍,最大杂质峰不超过对照品主峰峰面积的1.5倍。结论:本方法能灵敏、准确、可靠地进行杂质检测,对盐酸雷尼替丁制剂有关物质的控制有一定的意义。
OBJECTIVE To establish an HPLC method for determining the related substances of the preparations of Ranitidine Hydrochloride. METHODS The analytical column was Waters C18 （ 250 mm× 4.6 mm,5 μm） ;the mobile phase consisted of methanol -0.77% ammonium acetate （40：60） ; the detection wavelength was 320nm and the column temperature was 40 ℃. RESULT Sum areas of Ranitidine Hydrochloride preparations ＂related impurity were no 3 times wider than its control main area; the biggest area of Ranitidine Hydrochloride preparations ＂related impurity was no 1.5 times wider than its control main area. CONCLUSION The proposed method is accuracy, sensitive. It is suitable for determination of the related substances of the preparations of Ranitidine Hydrochloride.
出处
《天津药学》
2007年第6期12-15,共4页
Tianjin Pharmacy
